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| Therapy Name | Tebentafusp |
| Synonyms | |
| Therapy Description |
Kimmtrak (tebentafusp) is a gp100 antigen-specific human T-cell receptor (TCR) linked to an anti-CD3 antibody fragment, which activates cytotoxic immune response against gp100-expressing tumor cells (PMID: 24531387, PMID: 31336704, PMID: 32816891). Kimmtrak (tebentafusp) is FDA approved for use in HLA-A*2:01-positive metastatic or unresectable uveal melanoma patients (FDA.gov). |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Tebentafusp | Kimmtrak | ImmTAC-gp100|Tebentafusp-tebn|IMCgp100 | Kimmtrak (tebentafusp) is a gp100 antigen-specific human T-cell receptor (TCR) linked to an anti-CD3 antibody fragment, which activates cytotoxic immune response against gp100-expressing tumor cells (PMID: 24531387, PMID: 31336704, PMID: 32816891). Kimmtrak (tebentafusp) is FDA approved for use in HLA-A*2:01-positive metastatic or unresectable uveal melanoma patients (FDA.gov). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02570308 | Phase I | Tebentafusp | A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma | Completed | USA | GBR | ESP | DEU | CAN | 0 |
| NCT06246149 | Phase III | Tebentafusp | Adjuvant Tebentafusp in High Risk Ocular Melanoma (ATOM) | Recruiting | POL | NLD | FRA | ESP | DEU | BEL | 0 |
| NCT06626516 | Phase Ib/II | Tebentafusp Sargramostim + Tebentafusp Carmustine + Tebentafusp | Tebentafusp-tebn With LDT in Metastatic UM | Recruiting | USA | 0 |
| NCT06942442 | Phase II | Tebentafusp | A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma | Recruiting | USA | 0 |
| NCT02535078 | Phase Ib/II | Durvalumab Tebentafusp Tremelimumab | Phase 1b/2 Study of the Combination of IMCgp100 With Durvalumab and/or Tremelimumab in Cutaneous Melanoma | Withdrawn | USA | 0 |
| NCT05549297 | Phase III | Pembrolizumab + Tebentafusp Tebentafusp | Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM) | Recruiting | USA | POL | ITA | GBR | FRA | ESP | DEU | CHE | CAN | BEL | AUT | AUS | 0 |
| NCT06070012 | Phase II | Tebentafusp | Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma | Recruiting | USA | 0 |
| NCT06414590 | Phase II | Tebentafusp | Neoadjuvant Tebentafusp for Uveal Melanoma | Recruiting | USA | 0 |
| NCT07057596 | Phase II | Tebentafusp | Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma (NEO-TB) | Recruiting | ESP | DEU | 0 |
| NCT02889861 | Phase Ib/II | Tebentafusp | IMCgp100-401 Rollover Study | Terminated | USA | GBR | 0 |
| NCT03070392 | Phase II | Dacarbazine Ipilimumab Pembrolizumab Tebentafusp | Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma | Active, not recruiting | USA | POL | NLD | ITA | GBR | FRA | ESP | DEU | CHE | CAN | BEL | AUS | 2 |
| NCT06627244 | Phase II | Tebentafusp | Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma | Recruiting | USA | 0 |
| NCT05315258 | Phase II | Tebentafusp | Tebentafusp in Molecular Relapsed Disease (MRD) Melanoma (TebeMRD) | Active, not recruiting | GBR | 0 |